Reporting By Health Professionals

Thank you for visiting the MedWatch website to voluntarily report a serious adverse event, product quality problem or product use error that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device or dietary supplement.

In order to keep effective drugs and devices available on the market for use by you and your patients, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of all FDA-regulated products. Your report may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the drug or device and leads to increased patient safety.

What to Report on Form FDA 3500 Voluntary Adverse Event Report Form

FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care. (Events that occur during clinical trials under an Investigational New Drug (IND) application are mandatory reports and are submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions.) To submit your voluntary report:

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (Send only page 1 plus any continuation pages - do not send instruction pages). View Form FDA 3500 Instructions

User-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown.

Mandatory reports are made using Form FDA 3500A Mandatory Reporting Form. You can download the mandatory form as a .pdf document for printing. (At this time, FDA does not have a 3500A form that can be submitted electronically).

Form FDA 3500A Mandatory Reporting form is available online as a .pdf document for printing. (At this time, MedWatch does not have a 3500A form that can be submitted electronically). If you submit reports frequently, download a fillable version of the FDA 3500A form for local installation on your personal computer.